BEUDAMED
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    TRICYCLIC ANTIDEPRESSANTS I TX CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    SANSIBAR CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODEIFICATION TO IPLAN RT DOSE

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·May 8, 2014

    MEDFUSION

    FDA Adverse Event
    Malfunction ·MEDEX, INC.·Product code FRN·September 27, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 10, 2010

    BIOGRAPH VISION 600 PET/CT

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·February 11, 2025

    Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·January 8, 2020

    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·January 8, 2020

    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·January 8, 2020

    Cios care fusion system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019

    Cios Alpha VA20/ VA30 mobile X-Ray systems

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019

    Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·August 11, 2009

    Siemens Biograph mCT-S 40, model number 10248671. Medical Imaging Equipment.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·August 11, 2009

    Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·August 11, 2009

    Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·January 8, 2020

    Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·January 8, 2020

    Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·January 8, 2020

    Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·August 12, 2025

    SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·February 14, 2019